Preserving the integrity of clinical trials

A randomised controlled trial (RCT) is a type of clinical trial that has long been the gold standard for establishing the efficacy and safety of health interventions. The prospective design of RCTs, combined with random allocation of patients to a real-world intervention, minimises bias and allows for claims of causality. However, a trend is emerging, particularly within the growing field of digital health and artificial intelligence (AI)—the application of the RCT or clinical trial label to studies that fundamentally do not meet its core definition criteria.